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Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
ERIVEDGE capsule was administered as monotherapy at doses ≥ 150 mg orally daily in four open-label, uncontrolled, dose-ranging or fixed single dose clinical trials enrolling a total of 138 patients with advanced basal cell carcinoma (BCC). The median age of these patients was 61 years (range 21 to 101), 100% were White (including Hispanics), and 64% were male. The median duration of treatment was approximately 10 months (305 days; range 0.7 to 36 months); 111 patients received ERIVEDGE for 6 months or longer.
The most common adverse reactions ( ≥ 10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia (Table 1).
Table 1: Adverse Reactions Occurring in ≥ 10% of
Advanced BCC Patients
|MedDRA Preferred Term2||All aBCC1 Patients
(N = 138)
|All Grades3 (%)||Grade 3 (%)||Grade 4 (%)|
|Nausea||42 (30.4%)||1 (0.7%)||-|
|Diarrhea||40 (29.0%)||1 (0.7%)||-|
|General disorders and administration site conditions|
|Fatigue||55 (39.9%)||7 (5.1%)||1 (0.7%)|
|Weight loss||62 (44.9%)||10 (7.2%)||-|
|Metabolism and nutrition disorders|
|Decreased appetite||35 (25.4%)||3 (2.2%)||-|
|Musculoskeletal and connective tissue disorders|
|Muscle spasms||99 (71.7%)||5 (3.6%)||-|
|Arthralgias||22 (15.9%)||1 (0.7%)|
|Nervous system disorders|
|Skin and subcutaneous tissue disorders|
|1aBCC = Advanced Basal Cell Carcinoma.
2MedDRA =Medical Dictionary for Regulatory Activities.
3Grading according to NCI-CTCAE v3.0.
Read the Erivedge (vismodegib) Side Effects Center for a complete guide to possible side effects
Clinically relevant pharmacokinetic interactions are not expected between vismodegib and a substrate, inducer or inhibitor of cytochrome 450 enzymes or an inhibitor of P-glycoprotein (P-gp) or between vismodegib and gastric pH elevating agents [see CLINICAL PHARMACOLOGY].
Read the Erivedge Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 4/27/2016
Additional Erivedge Information
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